Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Brief analysis of the 'Guideline of manufacture of the finished dosage form' and its impact on the industry ***

Silvia Londero (Abschlußjahr: 2018)

Summary
Language: English
The "Note for Guidance on the Manufacture of Finished Dosage Form" was first published in 1996 and a refreshment of the information was needed and demanded by both applicants and authorities. The work for updating this specific guideline, which provides clarification on the content of the module 3 of the MAA concerning the manufacturing process description, has lasted for four years. The first concept paper was published in July 2013 and the final guideline in August 2017.
There are many changes that follow the implementation of this Guideline, due to the fact that more than ten years have passed between the first version and the revision. Moreover, in these years the world of the manufacturing transformed itself completely.
The aim of this work is to give a brief analysis of the chapters of this Guideline in respect to the relative MAA Dossier chapters and reflecting the latest experience from the applicant’s point of view, analysing the reactions and the comments of the stakeholders or the industry and the probable impact on the daily work of the manufacturers and marketing authorisation holders (MAHs).
Pages: 42